U.S. patent number 5,163,911 [Application Number 07/863,525] was granted by the patent office on 1992-11-17 for over-the-wire catheter.
This patent grant is currently assigned to Baxter International Inc., Peter Den Heijer, Paul S. Teirstein. Invention is credited to Sandra L. Cutter, Peter D. Heijer, Zohrab S. Kemkemian, D. Laksen Sirimanne, Paul M. Teirstein.
United States Patent |
5,163,911 |
Sirimanne , et al. |
November 17, 1992 |
Over-the-wire catheter
Abstract
A catheter system includes a guide wire, a working catheter and
a torque device for removably coupling the working catheter to the
guide wire while enabling rotation of the guide wire to the working
catheter. Advancement of the guide wire in a vascular system is
enabled by rotating the guide wire while the working catheter is
coupled thereto. A procedure for use of the catheter system
includes the simultaneous insertion of the guide wire and working
catheter into a vascular system and independent rotation of the
guide wire for steering the guide wire, with working catheter
coupled thereto, through the vascular system.
Inventors: |
Sirimanne; D. Laksen
(Huntington Beach, CA), Cutter; Sandra L. (Mission Viejo,
CA), Kemkemian; Zohrab S. (West Covina, CA), Heijer;
Peter D. (9571 AA Haren, NL), Teirstein; Paul M.
(La Jolla, CA) |
Assignee: |
Baxter International Inc.
(Deerfield, IL)
Den Heijer; Peter (Deerfield, IL)
Teirstein; Paul S. (Deerfield, IL)
|
Family
ID: |
27085678 |
Appl.
No.: |
07/863,525 |
Filed: |
April 3, 1992 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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608110 |
Oct 31, 1990 |
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Current U.S.
Class: |
604/164.13;
600/585 |
Current CPC
Class: |
A61M
25/01 (20130101) |
Current International
Class: |
A61M
25/01 (20060101); A61M 029/02 () |
Field of
Search: |
;604/164,96
;128/772,657 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Hirsch; Paul J.
Attorney, Agent or Firm: Hackler; Walter A. Schiffer;
Michael C. Condino; Debra D.
Parent Case Text
This is a continuation of application Ser. No. 07/608,110 filed on
Oct. 31, 1990 now abandoned.
Claims
What is claimed is:
1. A catheter system for use with a guide wire having a proximal
and a distal end, said catheter system comprising:
a working catheter adapted for sliding over said guide wire within
a vascular system;
a torquing device including means, removably coupling said torquing
device to the guide wire, for rotating the guide wire within the
working catheter and for sliding the guide wire within the working
catheter; and
coupling means for removably coupling said torquing device with the
working catheter to prevent sliding therebetween without limiting
rotatability of the guide wire within the working catheter.
2. The catheter system according to claim 1 wherein said torquing
device and coupling means are disposed near the guide wire proximal
end.
3. The catheter system according to claim 2 wherein said torquing
device includes a compressible member having means, defining an
opening, for enabling passage of said guide wire and fluid
therethrough when said compressible member is not compressed onto
the guide wire.
4. A catheter system comprising:
a guide wire having a proximal and a distal end, said distal end
including means for enabling steering of said guide wire through a
vascular system by rotation of the guide wire therein; a working
catheter adapted for sliding over said guide wire within the
vascular system;
a torquing device including means, removably coupling said torquing
device to the guide wire, for rotating the guide wire within the
working catheter and for sliding the guide wire within the working
catheter; and
coupling means for removably coupling said torquing device with the
working catheter to prevent sliding therebetween without limiting
rotatability of the guide wire within the working catheter.
5. The catheter system according to claim 4 wherein said torquing
device and coupling means are disposed near the guide wire proximal
end.
6. The catheter system according to claim 5 wherein said torquing
device includes a compressible member having means, defining an
opening, for enabling passage of said guide wire and fluid
therethrough when said compressible member is not compressed onto
the guide wire.
Description
BACKGROUND OF THE INVENTION
The invention generally relates to a catheter system for performing
transluminal angioplasty procedures and the like and is more
particularly directed to a steerable dilatation catheter having
advantages not found in conventional "fixed wire" catheters or
"over-the-wire" catheters.
A number of vascular conditions may be treated by percutaneous
transluminal coronary angioplasty in which a balloon catheter is
routed through the vascular system and positioned across a stenotic
lesion. The balloon is then inflated with a fluid to compress the
lesion against the artery wall in order to increase its effective
luminal diameter.
Apparatus suitable for such procedures currently available can be
classified as either a "fixed wire" catheter system or an
"over-the-wire" catheter system. A typical "fixed wire" catheter
system such as described in U.S. Pat. No. 33,166, dated Feb. 20,
1990, includes a guide wire with a dilatation, or working, catheter
permanently fixed thereto. The distinctive advantage of this type
of catheter is its relatively low profile, or small overall outer
diameter, which enables its use in smaller arteries and in
situations with more advanced stenosis in which an artery may be
closed to such an extent that a larger diameter catheter, such as
an over-the-wire catheter, may not be suitable.
The fixed wire catheter system is not without disadvantage. Because
the dilatation catheter is fixed to the guide wire at a distal end
thereof which includes a flexible steering portion or tip, the tip
itself is necessarily fixed, as well as it's length, thus limiting
the steerability of the fixed wire catheter. In addition, since the
fixed wire dilatation catheter system must be rotated, both the
wire and the balloon are is subject to distortion, particularly
"balloon wrapping", due to the rotation thereof which may result in
non-uniform inflation, limited ability or even inability for
inflation and deflation thereof.
In addition, with a fixed wire system the working catheter cannot
be replaced over the guide wire which can be left in situ to
establish an established path through the vascular system as
hereinafter described.
An over-the-wire catheter system, such as described in U.S. Pat.
No. 4,540,404, utilizes a separate guide wire. The guide wire may
first be inserted into a vascular system, and thereafter, a
dilatation, or working, catheter may be inserted thereover, until a
balloon member thereof is positioned across the stenotic lesion.
Advantageously, because the guide wire is not fixed to the working
catheter, the guide wire and working catheter may be inserted and
withdrawn independent of each other. Thus, if necessary, the guide
wire can be manipulated independently through a particularly
curvaceous artery. In addition, once the guide wire is in place,
the working catheter may be replaced as may be required to change
it for a working catheter with a different or larger balloon during
the angioplasty procedure. In view of these advantages, the
over-the-wire system has been considered more "user friendly" than
a fixed wire system.
Similarly, because the guide wire may be independently inserted and
removed from a vascular system, if a change in a tip shape, size or
type is deemed necessary to facilitate advancement or access, the
guide wire may be removed, leaving the working catheter in place
which subsequently provides an open channel for the replacement
guide wire. Once the guide wire is positioned past the stenotic
lesion, the working catheter can then be positioned to place the
balloon portion across the stenotic lesion for inflation. After
deflation and removal of the working catheter, the guide wire may
be left in place, enabling reinsertion or exchange of the balloon
catheter if necessary for a repeated angioplasty procedure.
Alternatively, if the guide wire is removed leaving the working
catheter, the lumen thereof, through which the guide wire had
passed, is now available for monitoring or other uses.
The present invention is directed to a fixable wire catheter having
a number of advantages, not available in prior art devices, as will
hereinafter be described in greater detail.
SUMMARY OF THE INVENTION
A catheter system in accordance with the present invention includes
a working catheter adapted for sliding along a guide wire within a
vascular system. Means are provided for enabling the working
catheter to be inserted and moved within the vascular system with
the guide wire and further enabling the guide wire to be rotated
within the working catheter during advancement of the guide wire
for steering the guide wire therethrough. This arrangement allows
simultaneous insertion of the guide wire and working catheter
without rotation of the latter, which rotation could result in
damage to or distortion of the working catheter, such as "balloon
wrapping" as hereinbefore described.
A catheter system in accordance with the present invention may also
include a guide wire sized for insertion into an animal vascular
system and having a proximal and a distal end. The distal end
includes a means for advancing the guide wire through the vascular
system which more particularly may include a flexible, yet
shapable, end portion.
The means provided for enabling rotation of the guide wire within
the working catheter allows the orientation and re-orientation of
the shapable flexible end portion to positions suitable for
advancing the guide wire, with the working catheter coupled
thereto, through the vascular system.
The means for removably coupling the working catheter to the guide
wire may include a compressible member having an opening
therethrough which provides means for enabling passage of the guide
wire and fluid therethrough when the compressible member is not
compressed and the guide wire has not been inserted.
An advantage of the present invention is the control of the length
of the guide wire tip portion extending beyond the working catheter
caused by the relative longitudinal placement of the distal end of
the guide wire with respect to the distal end of the working
catheter.
DESCRIPTION OF THE DRAWINGS
A better understanding of the present invention may be had in
connection with the following detailed description, taken in
conjunction with the accompanying drawings, in which:
FIG. 1 is a side view of the catheter system in accordance with the
present invention generally showing a guide wire, a working
catheter, a Y-connector, and a torquing device unit to couple the
working catheter to the guide wire as hereinafter described in
greater detail;
FIG. 2 is a cross-sectional view of the torquing device in
accordance with the present invention;
FIGS. 3a, b, c, and d are diagrammatic illustrations of relative
positions of the distal end of the guide wire having a shapable
portion thereon, and the distal end of the working catheter showing
how the working catheter may enable the steering of the guide wire
in accordance with the present invention;
FIG. 4 is a side view of the catheter system shown in FIG. 1 with
the torquing device separated from the Y-connector, enabling
independent longitudinal movement of the guide wire within the
catheter; and
FIG. 5 is a side view of the present invention including an
alternative standard type Y connector and showing how manipulation
of the guide wire within the working catheter is enabled when a
torquing device is decoupled from the Y connector.
DETAILED DESCRIPTION
Turning now to FIG. 1, there is shown a catheter system 10,
including a guide wire 12, having a proximal end 14 and a distal
end 16, the latter having a shapable flexible end portion 18
thereon, which may be of any suitable configuration, such as a
fine, helically wound coiled wire or the like, and a working
catheter 22 having a proximal end 24, a distal end 26, and an
inside diameter 28.
Disposed at the distal end 26 of the working catheter 22 is an
inflatable balloon 30 in a fluid communication with a port 34 via a
working catheter lumen 36. The configuration of the working
catheter 22, including balloon 30, as well as the guide wire 12,
may be of any conventional design as is well known in the art. In
addition, as is also well known in the art, a radiopaque marker 40
may be provided for use in determining the position of the distal
end 26 of the working catheter 22 as it is advanced through a
vascular system (not shown).
As shown in FIG. 1, control apparatus 50 may be provided which
includes a Y-connector 52, including the port 34 which provides
means for inflating and deflating the balloon 30 by injecting or
aspirating a fluid through the lumen 36 of the working catheter 22.
The Y-connector 52, as well as a coupling 56 joining the working
catheter 22 thereto, may be of conventional design. In addition, as
shown in FIG. 1, the outside diameter of the working catheter 22
may be in creased in portions 60, 62 by the use of elastomeric
coatings or metallic or polymeric sheathings for stiffening
purposes to enhance the strength thereof.
It can be appreciated that when the coupling 56 is attached, for
example by means of threads 64, to the Y-connector body 66, the
working catheter 22 is mounted in a non-rotatable relationship with
the control apparatus 50. The guide wire 12, however, extending
through the control apparatus 50, including couplings 70, adapter
72 and a torquing device 78, is rotatable within the working
catheter 22 as will be explained hereinafter in greater detail.
Turning now to FIG. 2, there is shown in cross-section the torquing
device 78, which is part of the control apparatus 50, generally
showing the adapter 72, along with a sleeve 82, and a shaft 84.
The adapter includes internal threads 88 for engagement with the
coupling 70 of the control apparatus and including a lumen 90
therethrough for communication with the lumen 28 of the working
catheter 22.
Disposed within the adapter 72 for rotation therein is a sleeve
head 94, having a face 96 pressed against a seal 98 for
facilitating rotation.
The sleeve 82 includes a body 100 having threads 102 adapted for
engagement with mating threads 104 on the shaft 84. When engaged, a
seal 106 is pressed against the sleeve 94 to prevent a fluid which
may be present in lumen 90 from passing therepast.
Ribs 108 on a body portion 110 facilitate the screwing of the shaft
84 into the sleeve 82 for compressing a compressible member, or tip
114, as it is forced against a tapered side diameter 116 of the
sleeve 82, thus compressing the tip 114 onto the wire 12 and
forming a seal for fluids within the lumen 90. Hence, it can be
seen that the shaft 84 and the sleeve 82 and adapter 72 provide
means for coupling the working catheter 22 to the guide wire 12 and
also means for enabling rotation of the guide wire 12 within the
working catheter 22. It is to be appreciated that since the working
catheter 22 is affixed to the Y-coupling 52 along with the adapter
72, when the tip 114 is compressed against the guide wire 12,
longitudinal sliding motion of the guide wire is prevented, but
rotation within the working catheter 22 is made possible.
A luer thread 120 is provided on the body portion 110 and disposed
in fluid communication with a central passage 122 of the shaft 84,
which enables fluid to pass therethrough and into the lumen 90 of
the adapter 72 and lumen 28 of the working catheter 22 for flushing
or other purposes.
Referring now to FIG. 1, working catheter 22, in operation, may be
slid over the guide wire 12 until a selected length of the shapable
flexible end portion 18 extends beyond a working catheter tip 126,
see FIGS. 3a, b, c and d. At that point, the working catheter 22 is
removably coupled to the guide wire 12 by rotation, or twisting, of
the shaft 84 into the sleeve 82, thereby compressing the tip 114
onto the guide wire 12. The working catheter guide wire 12 is then
inserted into a vascular system as in a conventional "fixed wire"
system and thereafter, rotation of the sleeve 82, as shown by the
arrow 128 (FIG. 1), results in the rotation of the guide wire 12
within the working catheter 22 and the shapable flexible end
portion 18 as shown by the arrow 130. This provides means for
orienting and reorienting the shapable flexible end portion 18 to
positions suitable for advancement of the guide wire 12 with the
working catheter 22 coupled thereto, through the vascular system
(not shown).
The shapable flexible end portion 18 includes a length thereof "1",
which is determined by the relative longitudinal placement of a
distal end tip 132 with respect to the distal tip 126 of the
working catheter 22 as shown in FIG. 3a. FIG. 3b shows the same
length, 1, with the guide wire 12 end portion 18 oriented
180.degree. from the orientation shown in FIG. 3a. Such
orientations facilitate the advancement and manipulation of the
guide wire 12 and working catheter 22 through the vascular
system.
As shown in FIGS. 3c and 3d, the working catheter 22 may be clamped
to the guide wire 12 at a position at which the longitudinal
placement of the distal tip 132 of the guide wire 12 with respect
to the distal tip 126 of the working catheter 22 is substantially
shorter, as may be necessary to facilitate advancement of the guide
wire 12, with the working catheter 22 attached thereto, through
various arcuate portions of the vascular system.
Turning to FIGS. 4 and 5, there is shown the torquer 72 decoupled
with the Y-connector 52 and an alternative Y-connector 140 having a
body 142 and port 144 for fluid access to the collector lumen 36
for inflating and deflating the balloon 30.
The torquing device 78 is shown decoupled to the Y-connectors 52,
140 in FIGS. 4 and 5. In this configuration the guide wire 14 may
be moved in a sliding fashion within the working catheter 22 as
indicated by the arrow 150, which results in adjusting the length,
1, of guide wire 12 projecting beyond the working catheter distal
tip 126. In this manner the guide wire 14 may be advanced within a
vascular system ahead of the working catheter 22. Alternatively,
when the torquing device 70 is coupled to either of the Y-members
52, 140, the working catheter 22 may be advanced with or,
manipulated with, the guide wire 12.
In accordance with the present invention, a procedure for the
insertion of a working catheter 22 through a vascular system
includes the steps of inserting the guide wire 12, having the
shapable end portion 18 into a vascular system (not shown). The
shapable flexible end portion is used to direct, or steer, the
guide wire 12 through the arcuate and bifurcated portions of the
vascular system. Thereafter, the working catheter 22 is inserted
over the guide wire 12 and coupled to the guide wire 12 with a
selectable length, 1, of the shapable flexible end portion 18
protruding from the working catheter 22.
Alternatively, the working catheter 22 may be disposed over the
guide wire 12 and coupled thereto as hereinabove described before
simultaneous insertion of the guide wire 12 and working catheter
into the vascular system.
Thereafter, the guide wire 12 may be rotated within the working
catheter 22 in order to orient the shapable flexible end portion to
a position suitable for continued advancement of the guide wire 12
with the working catheter coupled thereto within the vascular
system (see FIGS. 3a, b, c and d). With the proper orientation, the
procedure then includes advancing the guide wire 12 and working
catheter 22 in the vascular system.
Although there has been hereinabove described a specific
arrangement of a flexible over-the-wire catheter system in
accordance with the present invention, for the purpose of
illustrating the manner in which the invention may be used to
advantage, it will be appreciated that the invention is not limited
thereto. Accordingly, any and all modifications, variations, or
equivalent arrangements which may occur to those skilled in the art
should be considered to be within the scope of the invention as
defined in the appended claims.
* * * * *